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by ashwal
1841 days ago
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Important context is that all interventions that have assumed amyloid to be causal for Alzheimer's have failed to show material clinical improvement. So the bar is really much higher than "did remove plaque" and the prior should be this wasn't going to improve clinical response. The fact that it didn't and was still approved is a complete abdication of what the FDA preaches. It's rare to see a uniform response from those that report on drug dev. but it has been unequivocal - the FDA needs to get its shit together. I, personally, have little hope for that. |
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Also we are not really very interested in the effect on plaques, we are interested in things like cognitive behavior which are a lot easier to measure.